FDAClass IIDecember 30, 2020

Vanguard 360 Revision System Posterior Augment With recall

Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422

Why was Vanguard 360 Revision System Posterior Augment With recalled?

Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 098780 UDI Number: (01) 00880304482739 (17) 290501 (10) 098780

Product
Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422
Recalling firm
Biomet, Inc.
Quantity
21 units
Distribution
Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Korea, Japan, Netherlands.
Recall date
December 30, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls